ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2360

Patient Selection and Treatment Outcomes Using Preliminary Data-driven Definition versus the Established ASAS Definition of a Positive MRI of the Sacroiliac Joint in axSpA: Post-hoc Analysis from COAST-X

Xenofon Baraliakos1, Victoria Navarro Compán2, Pedro M. Machado3, Rebecca Bolce4, Hagen Russ5, Marcus Ngantcha6, Jeffrey Lisse6, Khai Jing Ng7, Sofia Ramiro8 and Denis Poddubnyy9, 1Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, 2La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, 3Department of Rheumatology, University College London Hospitals NHS Foundation Trust; and Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust; and Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, 4Eli Lilly and Company, Cincinnati, OH, 5Eli Lilly, Indianopolis, 6Eli Lilly and Company, Indianapolis, IN, 7Eli Lilly and Company, Madrid, Spain, 8Leiden University Medical Center, Bunde, Netherlands, 9Charite-Universitatsmedizin Berlin, Berlin, Germany

Meeting: ACR Convergence 2024

Keywords:

Session Information

Date: Monday, November 18, 2024

Title: SpA Including PsA – Treatment Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: To evaluate treatment outcomes based on the performance of a preliminary data-driven definition (PD) of a positive MRI of the SIJ in comparison to the established ASAS definition (ED) indicating eligibility into a clinical trial.

Methods: COAST-X is a phase 3, multicentre, randomized, double-blind, placebo-controlled study in nr-axSpA patients, receiving 80 mg ixekizumab every 2 or 4 weeks (wk), or placebo up to wk52. Baseline SIJ MRIs were scored by two central readers. Treatment arms were pooled for these descriptive analyses. The per protocol population was categorised using the total PD, PD-BME component, and the established ASAS definition (ED) of a positive SIJ MRI (Table 1). Baseline characteristics and the percentage of patients achieving ASDAS disease states, ASAS40 response and mean BASDAI change from baseline (CfB) are reported at wk16 based on each definition. Modified baseline observation carried forward (mBOCF) were used for missing data.

Results: At baseline, N=263 patients, the mean age was 39.6, 39.0 and 40.1, and percentage of males was 52.0%, 59.7% and 57.1% for PD (total), PD-BME and ED, respectively. Mean BASDAI and ASDAS were similar for PD, PD-BME and ED. 75% (196/263), 47% (124/263) and 62% (163/263) of patients were deemed MRI+ using PD, PD-BME and ED, respectively. At wk16, similar proportion of patients achieved ASAS40 in PD, PD-BME and ED (33.2%, 34.7% and 34.4%) and similar BASDAI CfB (-2.1, -2.3 and -2.1). The proportion of patients achieving an ASDAS inactive disease (10.7%, 12.9% vs 11.7%) or low disease activity (15.8%, 13.7% vs 14.1%) at wk16, was similar for PD, PD-BME and ED (Table 2).

Conclusion: Patients categorised using PD vs ED of a positive MRI, showed similar baseline characteristics and clinical outcomes after 16wks. The PD did not outperform the ED in the specificity of patient selection for a clinical trial in nr-axSpA.

Supporting image 1

Preliminary Data-driven Definition of a Positive MRI and the Established ASAS Positive MRI Definition

Supporting image 2

Baseline Characteristics and Clinical Outcomes at Week 16, for Patients Selected by Preliminary Data-driven Definition of a Positive MRI and Established ASAS Positive MRI Definition.

Disclosures: X. Baraliakos: AbbVie, 2, 6, 12, Paid instructor, BMS, 2, 6, 12, Paid instructor, Chugai, 2, 6, 12, Paid instructor, Eli Lilly, 2, 6, 12, Paid instructor, Galapagos, 2, 6, 12, Paid instructor, Gilead, 2, MSD, 6, 12, Paid instructor, Novartis, 2, 5, 6, 12, Paid instructor, Pfizer, 2, 6, 12, Paid instructor, UCB Pharma, 2, 5, 6, 12, Paid instructor; V. Navarro Compán: AbbVie, 1, 6, Bristol-Myers Squibb(BMS), 2, 6, Eli Lilly, 2, 6, Fresenius Kabi, 2, 6, Galapagos, 2, 6, Janssen, 2, 6, MoonLake, 2, 6, Novartis, 2, 6, Pfizer, 1, 6, Roche, 2, 6, UCB, 2, 6; P. Machado: AbbVie, 12, Personal fees, Bristol Myers Squibb, 12, Personal fees, Celgene, 12, Personal fees, Eli Lilly, 12, Personal fees, Galapagos, 12, Personal fees, GSK, 12, Personal fees, Janssen, 12, Personal fees, MSD, 12, Personal fees, Novartis, 12, Personal fees, Orphazyme, 12, Personal fees, Pfizer, 12, Personal fees, Roche, 12, Personal fees, UCB Pharma, 12, Personal fees; R. Bolce: Eli Lilly and Company, 3, 11; H. Russ: Eli Lilly and Company, 3, 11; M. Ngantcha: Eli Lilly, 3; J. Lisse: Eli Lilly and Company, 3, 11; K. Jing Ng: Eli Lilly and Company, 3; S. Ramiro: AbbVie, 1, 2, 5, 6, Alfasigma, 1, 2, 5, Galapagos, 1, 2, 5, Lilly, 1, 2, 6, MSD, 2, 5, 6, Novartis, 1, 2, 5, 6, Pfizer, 1, 2, 5, 6, UCB, 1, 2, 5, 6; D. Poddubnyy: AbbVie, 2, 5, 6, Biocad, 2, Bristol-Myers Squibb(BMS), 2, 6, Eli Lilly, 2, 5, 6, Gilead, 2, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Samsung Bioepis, 2, UCB, 2, 6.

To cite this abstract in AMA style:

Baraliakos X, Navarro Compán V, Machado P, Bolce R, Russ H, Ngantcha M, Lisse J, Jing Ng K, Ramiro S, Poddubnyy D. Patient Selection and Treatment Outcomes Using Preliminary Data-driven Definition versus the Established ASAS Definition of a Positive MRI of the Sacroiliac Joint in axSpA: Post-hoc Analysis from COAST-X [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/patient-selection-and-treatment-outcomes-using-preliminary-data-driven-definition-versus-the-established-asas-definition-of-a-positive-mri-of-the-sacroiliac-joint-in-axspa-post-hoc-analysis-from-coas/. Accessed .

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